21 CFR 862.3030 - Acetaminophen test system.

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§ 862.3030 Acetaminophen test system.

(a)Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

(b)Classification. Class II.

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